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RecoveryRX XTRA should qualify for a "Special 510k", 30 Day process
“The Special 510(k) Program” guidance document, issued in September 2019, describes an optional pathway for manufacturers that make certain well-defined modifications to their own legally marketed device. The guidance was developed to clarify existing policy and the types of changes that are appropriate for the program in an effort to improve the efficiency of 510(k) review, consistent with the FDA’s least burdensome principles. The program allows FDA and industry to rely on previous agency review of detailed information and manufacturers to provide the minimum required information necessary to establish substantial equivalence (SE) for a modified device. As a result, special 510(k)s are processed within 30 days of receipt by the Document Control Center instead of 90 days as for Traditional or Abbreviated 510(k)s.
Must be looking at the wrong stock, BIEL has 5 FDA Indications via 4 510Ks
K022404 - 8/8/2002, For the treatment of edema following Blepharoplasty
K152432 - 2/3/2017, Adjunctive treatment of musculoskeletal pain related to: (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee.
K190251 - 5/30/2019, Adjunctive treatment of postoperative pain
K192234 - 1/31/2020, Adjunctive treatment of musculoskeletal pain
It all depends on claims being made
srin.. the company has a great potential here, but their sales suck and they do not do a good job of communicating with the shareholders because they don't give a darn about us here. Sorry but true, wish I was wrong but so under water here it's hard to view it differently. Just hoping they can deliver on the 975k deal for 18 months going forward. If so, it may carry us to a half penny JMHO
Looking ahead to next Fridays close of the market for the week, I wonder if it will close at .0007 or .0008. It will be one of the two we all know that. Boom Zoom to the moon..
IMO, the Antenna is the only change to the RecoveryRX XTRA
In BIEL's 8/25 Call KN said, regarding the new RecoveryRX, it had an "oblong antenna" and their feeling was that it would not need a new 510k. He also mentioned a working prototype for a Rechargeable Device that would need a new 510k.
Changing the antenna shape to an elongated rectangle focuses the power more directly on a typical surgical incision.
The RecoveryRX XTRA has the same power as the RecoveryRx and the ActiPatch, 73mw, it is just directed in a rectangular pattern rather than a circular pattern.
The 2019 FDA Clearance k193234 for Musculoskeletal Pain states that the ActiPatch comes with either a 12cm or a 6cm antenna. This shows very clearly that different antenna configurations are not a significant factor for the FDA.
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192234.pdf
Notes due in 2023 $2,063,626 with interest.
https://www.otcmarkets.com/otcapi/company/financial-report/344738/content
Declining Sales Cheers!~~
Wouldn’t you agree that since the RecoveryRX device is already indicated and cleared for post operative pain care that any ancillary healing benefit makes additional FDA submissions unnecessary and therefore making your point moot?
After all the point is the device is being placed on the wound post op regardless..
BIEL
Please see my post #299891
And besides, your post still doesn't indicate what if anything posted was false.
Please see my post #299889
BIEL
Seriously?
The treatment of post op pain is not an integral part of post op “ wound care “ ?
Below you will find a link to PUBLISHED STUDIES that demonstrates the efficacy of RecoveryRX in accelerating wound healing along with photos documenting each step of the wound healing process.
http://www.recoveryrx.co/clinical-research/chronic-wounds/
RecoveryRX is indicated for postoperative use for surgical pain care cleared by the FDA.
Is accompanied ancillary accelerated wound healing a bad thing?
Is it??
Seriously..
BIEL
Well, that is a compelling argument!!
Would you care to elaborate on which aspect you believe to be false?
That wound care and pain relief are different indications?
That clearance for enhanced pain relief via minor changes to device should be easy?
That it might take until Q3 2023 for clearance of RecoveryRx Extra?
The indications for use are critically important
At least they usually are for investors in the drug/device space.
Yes, there is a market just for pain relief. No one is arguing that there isn't. Being able to claim advance healing properties with an FDA clearance would certainly enhance that market potential. I think that everyone agrees on this.
Will BIEL be claiming pain relief without the healing properties? I may have misunderstood, or misremembered. I recall some discussion about healing.
Eye roll. First it was a 2 day argument about 975000 units. Now it’s a semantics argument about approvals vs. clearances and what actipatch is meant for. Who exactly is that argument important to? Maybe the oem partners are watching this discussion closely because they may change their minds. Lmfao. Yeah but.
AGAIN, "post-op wound care." not "post-op pain."
Yes, the ActiPatch is cleared by the FDA for pain. But we are talking about the indication of WOUND CARE, not the indication of PAIN.
@@ (eye roll)
PAY REAL ATTENTION, ddls yo, it is a Crystal Bright FUTURE for BIEL, this Company is a WINNER and Actipatch ABSOLUTELY is marketable !!!
INCREASING SALES --- HUGE!!!!!
.05c is ABSOLUTELY DOABLE
.10c is VERY DOABLE
.20c is PROBABLY DOABLY -- ALL BEFORE any share structure attention !!!!!!!
BIEL$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
WORLDWIDE WARNING !!! ATTENTION All the Smart and INTELLIGENT People / Investors!!! BE ADVISED --- " Sales-Track " IMAGINARY story is an ABSOLUTE BS, don't you, Beautiful People, BIELieve it one bit !!!!!!!!!!!!!!!!!!!!! WARNING !!!!!!!!!!!!
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
WRONG AGAIN AGAIN..
Cleared for POST OPERATIVE PAIN..Lol
“The RecoveryRX specified submission for and the FDA approval of the RecoveryRX medical device is for post op care ie post op pain relief.”
https://www.nsmedicaldevices.com/news/fda-bioelectronic-recoveryrx-pain/#
The truth Hurts so good!!
Placebic Junk Post!!
We won't know if a 510(k) is required until the FDA responds to the Q submission.
Increase in power? I'm thinking yes. They probably need a new patent too.
But it's all pie in the sky. I can barely see that pie, it's so high in the sky.
Meanwhile... Q3 just ended. Revenues for Q3? prediction? Did Staelin promise any stocking orders in Q3?
WRONG AGAIN. cleared for "PAIN," not "WOUND CARE."
I'm talking about "wound care," not "pain."
The clinicals studied ONLY chronic pain. NOTHING to do with wounds.
And it's a device, so it's CLEARED by the FDA, not APPROVED.
LOL Too easy.
It doesn't matter if this is FDA cleared or not, it's placebic junk that has never been generally accepted and it won't sell well just like their other crap. If it doesn't sell well on Amazon with KT~Recovery+Wave which is a 100 times larger market at least then RX, it's not going to sell. ActiBand in 2006 flopped, and this is a flopper also.
Declining Sales Cheers!~ ~
Wound care versus pain relief
Are they the same? I think wound care is different. Any claim that the product speeds the healing process will likely need a new application. New clinical evidence.
I agree that a minor change to the shape of the antenna and the already cleared claim of pain relief should be easy.
Keep in mind, with the FDA and BIEL, easy still means 3rd quarter 2023.
This isn't saving this junk, SIMPLE!
Declining Sales Cheers!~~
I second that. GO BIEL!!!
EXACTLY!! Early-Call Biel Post Of The Day Award!!
WRONG AGAIN..
“Also, it's important to note that the ActiPatch is not clinically proven to be effective at recovery wound care. It's not cleared by the FDA for that indication and cannot be marketed for that indication”
The RecoveryRX specified submission for and the FDA approval of the RecoveryRX medical device is for post op care ie post op pain relief.
This is too easy..LMAO
“FDA approves BioElectronics’ RecoveryRx device to treat postoperative pain”
“BioElectronics has secured approval from the US Food and Drug Administration (FDA) for its RecoveryRx medical device to treat postoperative pain.“
“RecoveryRx will help reduce postoperative pain and exposure to long-term effects of opioid/NSAID therapy, said the company in a statement.
According to the company, less than 50% of patients who undergo surgery report adequate postoperative pain relief.
The approval allows RecoveryRx drug-free therapy to the 15 million Americans who experience postoperative pain from 25 million surgeries per annum.
In addition, RecoveryRx therapy is having a significant market opportunity among the 7 million chronic wound patients with debridement and negative vac therapy treatments.
RecoveryRx uses pulsed electromagnetic therapy to decrease pain and inflammation, helping to accelerate patient recovery and improved comfort.
BioElectronics noted that RecoveryRx has been clinically demonstrated to significantly reduce postoperative pain and the use of narcotic pain medication postoperatively.
The device significantly reduces the required level of pain medications in postoperative surgical recovery, helping to decrease narcotic medication use and side effects and potentially limit the incidence of chronic pain.
BioElectronics president Andrew Whelan said: “We are delighted that the FDA has recognized the potential of RecoveryRx in transforming postoperative pain care.
“RecoveryRx, with its high degree of safety, excellent clinical evidence of effectiveness and exceptional cost-benefit, will become the standard of care.”
The firm is also engaged in the preparation of documentation for its ActiPatch 510(k) to receive expanded approval to treat general musculoskeletal pain. BioElectronics plans to file the application within the next few weeks.“
https://www.nsmedicaldevices.com/news/fda-bioelectronic-recoveryrx-pain/#
BiEL
Sales-Track currently showing steep sales declines in Q3.
Declining Sales Cheers!~~
It doesn’t matter how many seeds one plants, it’s more about caring and watering those plants. We have many left uncared for and they dwindled away or died. No nobody famous saying that, just little ole me. JMHO GLTY Have a nice weekend.
Thank you Kelly & TEAM
"Don't judge each day by the harvest you reap but by the seeds that you plant. -Robert Louis Stevenson #planting #gotthisdad #teambiel"
https://twitter.com/Kel928/status/1509275973539225603
https://seekingalpha.com/news/3818835-bioelectronics-pain-relief-device-recoveryrx-cleared-by-mexican-regulator-for-import?utm_source=advfn.com&utm_medium=referral
https://otcbrace.com/collections/actipatch
https://www.facebook.com/watch/?v=151593766797161
https://protibolecinska-zanka.com/?fbclid=IwAR2pWP6ikD-vxB6XB5mGfH47CwWEuABcPbBaT0xb5YN9xGxz504xVuOKlCk
https://www.pressreleasepoint.com/bioelectronics-recoveryrx-pain-relief-device-receives-clearance-cofepris-launching-distribution
INCREASING Sales Cheers~~
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
PAY REAL ATTENTION, ddls yo, it is a Crystal Bright FUTURE for BIEL, this Company is a WINNER and Actipatch ABSOLUTELY is marketable !!!
INCREASING SALES --- HUGE!!!!!
.05c is ABSOLUTELY DOABLE
.10c is VERY DOABLE
.20c is PROBABLY DOABLY -- ALL BEFORE any share structure attention !!!!!!!
BIEL$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Srin, with all due Respect, Man, you are WASTING your VALUABLE time................On the other hand, may be not - All the Smart, Intelligent People/Investors will be able to read your post and make the right decision, without any influence from any BS!!!!!
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
BWAAAAA BWAAAAAA BWAAAAAAAAAAA
INCREASING SALES!!! VZOOOOOOM to the MOOOOOON !!!!!!!!!!! And those who are waiting for it to fall or to go bankrupt or to fail or.....could wait till.......HEHEHEHE....https://media.tenor.com/videos/5ae934e996c417ca96207ad373c1bef7/mp4 ...
Accept this FACT!!!!!
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
YIKES!! NOTHING, ABSOLUTELY NOTHING will stop what is obvious and coming !!!!!!!!!!!!!!!!!!!! Of course hic-ups are present, but......
Watch this, Ladies and Gentlemen, explode like a volcano Vesuvius ( https://www.history.com/this-day-in-history/vesuvius-erupts ) ---- ..one day BOOOOOOOM, VZOOOOOOOOM, to the Moon !!!!!!!!!!!!! And those who are waiting for it to fall or to go bankrupt or to fail or.....could wait till.......HEHEHEHE....https://media.tenor.com/videos/5ae934e996c417ca96207ad373c1bef7/mp4 ...
This MIRACLE DEVICE ( Actipatch ) is worth..................$$$$ BILLIONS ( in time, of course, IMO )!!
All the FDA conclusions are TRUE and RESPECTABLE !!!!
BIEL, the MOST INTERSTING company in the World and Actipatch is ABSOLUTELY MARKETABLE !!
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Thank you for your continuing continued interest in BIEL. I know if it was me that carried that kind of concern, I would not spend any amount of time on a daily negative basis. GEEZ, it would not be good for my health or anyone's health for that matter. However, I am in total disagreement with your daily reminders and will continue to BUY-BUY-BUY!!!
You forgot the Costco twin pack rollout. LMAO
Declining Sales Cheers!~~
The new device won't be accepted as usual along with the rest of the placebic junk.
Declining Sales Cheers!~~
When family and friends are out of risk money to give this company operating loans next year it will be game over. SIMPLE! And there's not a commercial bank that will either, not with their track record. Operating loans due in 2023 are $2,063,626 with interest, without interest about $1,840,000. Do you smell their toast on fire?
Declining Sales Cheers!~~
UK rollout - the Germany rollout - B.Braun deal that lasted 6 months - the UK NIH acceptance of RecoveryRx - the rollout in Canada - the rollout on Asia - all the distributor deals for 10 years that never produced jack.
+
CVS Walgreens, Walmart, Target, RiteAi
+
5 FDA clearance
+
KT Wave
+
Donjoy
+
Airway roll-out hype
+
Selling in 32 countries
USA https://www.bielcorp.com/ https://www.recoveryrx.co/ https://www.donjoyperformance.com https://www.kttape.com
Greece https://gmtpshop.com/shop/physicotherapeftika/siskeves-ilektrotherapias-tens/recovery-rx/
Spain https://www.prim.es/
Mexico https://globaltech.com.mx/
Saudi Arabia https://www.stada.com/
Bahrain https://www.stada.com/
Lebanon https://www.clinovations.com/
Qatar http://www.mdmedical.co/index.html
Oman http://www.mdmedical.co/index.html
United Arab Emirates http://www.mdmedical.co/index.html
Kuwait http://www.mdmedical.co/index.html
Slovenia https://protibolecinska-zanka.com/?fbclid=IwAR2pWP6ikD-vxB6XB5mGfH47CwWEuABcPbBaT0xb5YN9xGxz504xVuOKlCk
Poland https://www.ubuy.com.pl/en/product/2DQGJO8-kt-tape-kt-recovery-wave-electromagnetic-pain-relief-device
Romania https://www.directpharma.ro/
Estonia https://msa.sm.ee/ctrl/en/MeditsiiniSeade/andmed/17178 https://monger.eu/kttape/en/toode/kt-recovery-wave/
Lithuania https://www.ubuy.lt/en/product/MPTPWE-actipatch-knee-pain-advanced-long-lasting-relief-packaging-may-varry
Japan https://www.u-buy.jp/en/product/2DQGJO8-kt-tape-kt-recovery-wave-electromagnetic-pain-relief-device
United Kingdom https://www.kttape.co.uk/products/kt-recovery-wave-%E2%84%A2
https://www.healthstuff.co.uk/en/us/ActiPatch-Knee-Pain-Reviews/r-3215.aspx
https://www.chemist-4-u.com/
Ireland https://www.ishpharmacy.com/p/actipatch-electromagnetic-pulse-therapy-back-pain/actipatch-back
Germany https://www.amazon.de/-/en/ActiPatch-Knee-Joint-Pain-Kit/dp/B00RLLMVNK
Austria http://www.actipatch.at/
Australia https://actipatch.com.au/
Canada https://airwaysurgical.ca/
New Zealand https://thebalancedpet.co.za/shop/healfast-therapy-petpatch-loop/
Italy https://oneglobebio.com/
Finland https://kir-fix.fi/kauppa/actipatch-laakinnallinen-laite-kroonisen-kivun-hoitoon/
Sweden https://www.actipatch.se/
Korea https://www.huons.com/eng/home.php?go=main
South Africa https://www.adcock.co.za/
Bangladesh https://www.facebook.com/mhplbd/
Taiwan http://www.abmt.com.tw/
China https://cicdtech.en.made-in-china.com/product/TZiasMQvCpYj/China-Drug-Free-Pain-Relief-Electromagnetic-Pulse-Medical-Physical-Therapy-Equipment.html
The stock price goes back to years before all of this. KN tweeted hard for a while when he had to publish the terrible earnings report and then went silent for over a month. He proudly tweeted a picture of the 3000 units it ships to Italy on 8/25. Can't they even sell 3000 a month? Or do they keep silent because there's something so big that they don't care about the little things?
I am preparing for BIEL’s ascent. Are you???
BUY $BIEL$
Is a new 510(k) required for a modification to the device?
The RecoveryRX XTRA has the same electronics, battery, off/on function as the Cleared RecoveryRx device. The change is in the Antenna shape, originally circular to rectangular to better fit surgical wounds.
FDA
Is a new 510(k) required for a modification to the device?
Introduction
Medical devices undergo frequent modifications to their design and materials due to many things; changes in the supply chain, continuous process improvement, or to keep pace with technological innovations that can improve how these devices work in a clinical setting. Major modifications to the device likely require premarket review by the FDA, while minor changes likely do not.
A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is significantly changed or modified in design, components, method of manufacture, or intended use. Significant changes or modifications are those that could significantly affect the safety or effectiveness of the device, or major changes or modifications in the intended use of the device (21 CFR 807.81(a)(3)).
The regulatory language provides essential flexibility instead of rigidly defining the types of changes that require FDA review. Appropriate application of this flexibility enables innovation and ensures Agency oversight only when necessary. For some types of changes to a device, the Agency believes that submission of a new 510(k) is not required and that reliance on existing Quality System (QS) requirements (21 CFR 820) is the least burdensome approach to reasonably assure the safety and effectiveness of the changed device.
https://cacmap.fda.gov/medical-devices/premarket-notification-510k/new-510k-required-modification-device#:~:text=Major%20modifications%20to%20the%20device%20likely%20require%20premarket,design%2C%20components%2C%20method%20of%20manufacture%2C%20or%20intended%20use.
Doesn't make any difference no doctors or surgeons use PSWT/PEMF much anymore only in Sports medicinal once in a while.
Declining Sales Cheers!~~
XTRA clearance a long way off -- BIEL has only submitted a Q-submission so far.
Regarding clinical trials -- BIEL has been famously inept at conducting clinical trials themselves. The plantar and back studies that earned the FDA clearances were independent studies. BIEL needs some independent researchers to do the clinical trials.
Also, it's important to note that the ActiPatch is not clinically proven to be effective at recovery wound care. It's not cleared by the FDA for that indication and cannot be marketed for that indication.
BWAAAAA BWAAAAAA BWAAAAAAAAAAA
INCREASING SALES!!! VZOOOOOOM to the MOOOOOON !!!!!!!!!!! And those who are waiting for it to fall or to go bankrupt or to fail or.....could wait till.......HEHEHEHE....https://media.tenor.com/videos/5ae934e996c417ca96207ad373c1bef7/mp4 ...
Accept this FACT!!!!!
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Buy & sell totals for the week 9/26-9/30
Buys 15,303,721 - Sells 15,900,161
Declining Sales Cheers!~~
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PHOENIX, June 13, 2018 (GLOBE NEWSWIRE) -- Uptick Newswire welcomed Andy Whelan, President of BioElectronics Corporation (OTC Pink:BIEL) ("the Company") back onto the "Stock Day" podcast. Andy spoke with Everett about their progress in the US market, UK market, the new product, the US FDA, and new distributors and potential partnership opportunities.
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch(R) Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx(R) Devices for chronic and post-operative wound care; Allay(R) Menstrual Pain Therapy. For more information, please visit http://www.bielcorp.com/
The Company is currently pursuing multiple US partnership opportunities that are partially contingent on additional FDA clearance for the treatment of musculoskeletal pain, back pain, knee pain, muscle, hip, carpal tunnel, etc. Whelan said,"Patience is key throughout this process. It's going as well as it can." Additionally, the Company anticipates solidifying deals with two new major distributors in the Asian and Eastern European markets.
The Company's product development and regulatory clearances are going well. Now, with pre-submission clearance, the 510(k) relief of musculoskeletal pain market clearance application will be filed by the end of June.
The US FDA has recently implemented an Innovation Program seeking "Breakthrough Devices" to Prevent and Treat Opioid Use Disorder. Opioids are routinely used for post-operative pain. Our United Kingdom ActiPatch User Registry accounts that 71% of opioid customers report a moderate (50%) to complete (100%) elimination in opioid medication use. The Company plans to submit its post-operative pain relief market clearance application into this program. The FDA's assistance, participation, and approval will provide credence and accelerate product market acceptance.
The Company has begun shipments of its new single box kinesiology tape product to be used for back, knee, hip, and muscles and joints in lieu of the back wrap, knee wrap and muscle and joint adhesives. The kinesiology tape is easier to use, reduces product costs, and retail shelf space requirements.
The Company is transitioning its United Kingdom over-the-counter sales and marketing from the front of the store to behind the counter to expand product availability from a few stores to all 14,000 pharmacies. Most pharmacies obtain daily product deliveries and most people in the UK qualify for free prescriptions.
Whelan is confident in the direction the Company is moving, and cites the unique nature of their products as a factor that helps the Company stand out in the global medical electronics industry. Whelan then said, "This is one busy little Company."
"Stock Day" host Everett Jolly stands by his assessment from his April interview with the company that the stock is very undervalued. BioElectronics Corporation trades on the OTC Pink market under the ticker symbol BIEL. Shares are currently selling at 0.0037, up over 100% since April.
For more details about the Company's recent FDA meetings, potential partnership opportunities, and attempts to combat the ongoing opioid crisis, follow the link below to hear the full interview.
https://upticknewswire.com/featured-interview-ceo-andrew-whelan-of-bioelectronics-corp-otc-pink-biel-3/ ;
About BioElectronics Corporation
BioElectronics develops and manufactures unique nonprescription affordable neuromodulation medical devices. The Company's technology platform is for the treatment of central sensitization, which is now widely accepted as the physiological explanation for many neurological disorders, and specifically chronic pain. Central sensitization is difficult, if not impossible, to address through pharmacotherapy without having a detrimental impact on normal physiologic function. Moreover, pharmacological and masking therapies (creams, heat patches, TENS etc.) have limited effectiveness for chronic pain due to their transient nature. BioElectronics' electromagnetic stimulation therapy has the distinct advantage of being safe, affordable, long lasting, and effective pain relief.
Contact: Paul Knopick, 940.262.3584, pknopick@eandecommunications.com
FREDERICK, MD., May 31, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), maker of advanced medical devices announces that B. Braun Ltd, of Sheffield, UK has recently completed development of its same day surgical TOTAL Pathway program for joint replacements which includes BioElectronics medical devices. The program is being launched by B. Braun’s UK […]
FREDERICK, MD, May 29, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com reports that it has cancelled today’s scheduled US Food and Drug Administration meeting. “The FDA’s response to our questions, suggestions, and instructions are more than adequate for us to proceed with filing of the formal 510(k) Market Clearance Application,” stated Ian […]
FREDERICK, MD , May 11, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to report on the outcome of its Pre-Submission meeting on May 9th, 2018 with the US Food and Drug Administration (US FDA). The FDA’s Pre-Submission Program is designed to organize and give guidance and feedback on clinical data and what […]
FREDERICK, MD, May 02, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that two meetings have been scheduled with the US Food and Drug Administration (FDA) to seek expanded over-the-counter (OTC) clearances for their drug-free, wearable medical devices. The first meeting will take place on May 9th, 2018 to […]
PHOENIX, April 26, 2018 (GLOBE NEWSWIRE) — Uptick Newswire was thrilled to have Keith Nalepka, VP of Marketing & Sales at BioElectronics (OTC Pink:BIEL) (“the Company”), return to the “Stock Day” podcast. The company has been working hard lately to expand the United Kingdom market with B. Braun in the surgical market and the product […]
FREDERICK, MD, March 19, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce the commencement of a clinical study investigating the efficacy of its RecoveryRx® device for postoperative pain management and recovery following total knee arthroplasty surgery. Currently there are 700,000 total knee replacement surgeries in the US alone and are projected to grow 673% to 3.5 million procedures per […]
PHOENIX, Jan. 22, 2018 (GLOBE NEWSWIRE) — The Uptick Newswire “Stock Day” podcast keeps investors up to date on the latest penny stock news by bringing transparency in the micro-cap side of the market. Connect with “Stock Day” and to over 600+ CEO interviews on the OTC, Pink Sheets and micro-cap news from around the world […]
FREDERICK, MD, Jan. 09, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced wearable consumer pain management medical device, ActiPatch, announced today that CARE Pharmacies has committed to introducing ActiPatch, Musculoskeletal Pain Therapy medical device to its patients. “With the current opioid crisis here in the United States, as pharmacists, we […]
FREDERICK, Md., Jan. 04, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com makes wearable, drug-free chronic pain therapy medical devices. It is pleased to announce that the UK’s government funded public health service, National Health System (NHS), has approved our application to cover and pay for ActiPatch® Musculoskeletal Pain Therapy. The NHS estimates that almost half […]
FREDERICK, MD, Dec. 12, 2017 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced wearable consumer pain management medical device, ActiPatch, announced today the launch of ActiPatch for Over-The-Counter, drug-free pain relief as an alternative to Opioids. ActiPatch is approved by the FDA for Over-The-Counter sales for the adjunctive treatment of pain […]
BioElectronics Receives FDA Pre-Submission Approval for its Relief of Musculoskeletal Pain Market Clearance Application
FREDERICK, MD , May 11, 2018 (GLOBE NEWSWIRE) -- BioElectronics Corporation (BIEL) , www.bielcorp.com is pleased to report on the outcome of its Pre-Submission meeting on May 9th, 2018 with the US Food and Drug Administration (US FDA). The FDA’s Pre-Submission Program is designed to organize and give guidance and feedback on clinical data and what regulatory pathway should be followed to get market clearance. The focus of the May 9 pre-submission meeting was in discussing the FDA’s feedback on the clinical outcomes and statistical techniques used in reporting the back-pain study.
Upon reviewing pre-submission information on the ActiPatch® back-pain study (https://clinicaltrials.gov/ct2/show/NCT03240146), the FDA provided positive feedback on the clinical results, and guidance on a 510(k) submission to obtain expanded market clearance for over-the-counter (OTC) treatment of musculoskeletal pain. This would make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans (one in two adults) who are suffering with some form of musculoskeletal pain. While ActiPatch is already FDA cleared for treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (1 million annually), expanded market clearance would allow additional products for the back (42 million), neck (19 million), hip (9 million), shoulder (11 million), carpal tunnel (12 million) and many other musculoskeletal complaints.
The company was represented by their clinical R&D team comprising: Sree Koneru, Ph.D., VP Product Development, Ian Rawe, Director Clinical Research of BioElectronics (BIEL), Kenneth McLeod, Ph.D. Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D. Professor Duke University. Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.
An additional pre-submission meeting is scheduled with the FDA on May 29th, 2018 to seek expanded indications in a separate application for OTC treatment of pain and edema following surgical procedures for its RecoveryRx® medical device.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; Allay® Menstrual Pain Therapy. For more information, please visit www.bielcorp.com
BioElectronics VP of Sales Discusses Pre & Post-operative Pain Relief Surgical Program in "Stock Day" Interview
PHOENIX, April 26, 2018 (GLOBE NEWSWIRE) -- Uptick Newswire was thrilled to have Keith Nalepka, VP of Marketing & Sales at BioElectronics (OTC Pink:BIEL) ("the Company"), return to the "Stock Day" podcast. The company has been working hard lately to expand the United Kingdom market with B. Braun in the surgical market and the product opportunity from the recent National Health Service payment approval for its ActiPatch® medical device.
BioElectronics is with B. Braun Medical, Ltd.UK to initiate the "Total Pathways Program" program into B. Braun's 26 geographic markets. The program is for pre-habilitation (treatment that happens prior to surgery) and post-operative recovery. This new program will benefit the majority of the 160,000 UK annual knee, hip, or joint replacements patients. According to Keith, BioElectronics is not just trying establishing a brand, but "to establish the process to a standardize care for pre and post-operative pain."
The company is immensely proud of their team for getting their concept through to the National Health Service (NHS) in the UK. In addition to successes here, the company is hoping to utilize their overseas success by applying data to their US-based efforts.
There are some great potential partnerships currently being discussed at BioElectronics, with the closing of a significant deal just on the horizon.
BioElectronics Corp is approaching their upcoming FDA meetings with confidence. "We have the data to make a very strong case for both broader musculoskeletal and post-operative pain relief indications," said Nalepka. "It's an exciting time for the company, and a really cool little product."
For more details on the Total Pathways Program, news about a partnerships, and information about the company's upcoming meetings with the FDA, follow the link below to the full interview.
https://upticknewswire.com/featured-interview-vp-of-sales-keith-nalepka-of-bioelectronics-corp-otcpink-biel-3/ ;
About BioElectronics
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.
Contact: Paul Knopick, 940.262.3584, pknopick@eandecommunications.com
Safe Harbor Statement
Certain statements contained herein are "forward-looking statements," (as defined in the Private Securities Litigation Reform Act of 1995). BioElectronics Corp. cautions that statements and assumptions made in this news release constitute forward-looking statements; the company makes no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time statements are made. These statements may address issues that involve significant risks, uncertainties, and other estimates made by management. Actual results could differ from current projections or implied results. BioElectronics Corp. undertakes no obligation to revise these statements following the date of this news release.
About Uptick Newswire
Uptick Newswire is a private company reaching out to the masses keeping investors and shareholders up to date on company news and bringing transparency to the undervalued, undersold, micro-cap stocks of the market and is the sole producer of the Uptick Network "Stock Day" Podcast. The Uptick Network "Stock Day" Podcast is an extension of Uptick Newswire and has recently launched the Video Interview Studio located in Phoenix, Arizona.
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BioElectronics Up-Date |
Dear Fellow Shareholders, This letter is to report on our recent progress in marketing and product development. We have established the following:
We are continuing to solicit new international and domestic sales and marketing partners for distribution and licensing, while strengthening our relationship with existing partners. To aid in this effort we have engaged an accomplished sales and marketing pharmaceutical consultant to assist in introduction and negotiations of sales and marketing partnerships. US Market Clearance ActiPatch®, Musculoskeletal Pain Therapy We are in the process of expanding the US market clearance from relief of osteoarthritis of the knee pain and plantar fasciitis. Our goal is to obtain general clearance for musculoskeletal pain. To achieve this, we have submitted a chronic back pain clinical study to the US FDA as a formal Pre-Sub. The initial meeting with the FDA is tentatively scheduled for May 9th. Prior guidance from the FDA indicated that a third clinical study was required before expanding the current market indications to cover all musculoskeletal pain. We are hopeful that the process will be completed rapidly, however we will not have a good estimate of this market clearance date until the completion of the May 9th meeting. Postoperative Recovery and Pain We have submitted a formal Pre-Sub to the US FDA for guidance in obtaining market clearance for the palliative treatment of postoperative pain and edema. The application is supported by postoperative clinical studies on breast augmentation and caesarean section. Marketing Expansion We believe that expanded market clearance from the FDA will enhance the market value and attractiveness of the ActiPatch product line. Our economic and clinical studies for the National Health Services allowed us to gain a drug tariff listing for reimbursement in England and Wales allowing the following:
The ActiPatch registry studies report that people buy the device because it is effective, drug-free, has no harmful side effects and overall improves quality of life. We are continually working to solve existing minor issues with the use of ActiPatch. To improve the product, we are introducing custom-design kinesiology tape strips to attach the device to the body. Aside from improving user comfort, this allows us to promote a single multi-purpose box with the added benefit of reducing retail shelf space. We believe this will then allow us to sell the 7-day trial devices from pharmacy shelves. B. Braun UK This is an important development for BioElectronics. B Braun has been using RecoveryRx to improve recovery following joint replacement for many years, although in limited surgeries. However, new advances in day surgery for joint replacement have expanded our opportunity. B. Braun has recently completed a pilot program in the UK evaluating day for joint replacement. The United Kingdom's Group day surgery program for knee and hip replacement patients and is now being implemented on a national basis. Currently there are 80,000 procedures per year involving B Braun. The "fast-track" same day hip and knee replacements are being supported by hospital physiotherapy teams visiting the patient at home and communicating using a special wireless technology tablet. Upon hospital discharge, each patient will be given an ActiPatch medical device and a prescription for 6 additional devices to help accelerate recovery and mitigate the postoperative pain. A similar program is in development for spinal surgeries. On an international level, B. Braun's 54,000 employees are in 60 countries and are separated into additional divisions for hospital care, surgical products, outpatient care, and home care services. It is anticipated that B. Braun's German Group will roll out the same day hip and knee replacement program in the next few months.
Smart Insole – Heel Pain Relief We have redesigned the Smart™ Insole plantar fasciitis insole to enhance user comfort. We are awaiting a written License and Supply Agreement for the product. Clinical Research to Expand Market Clearance and Acceptance Allay®, Menstrual Pain Therapy 28% of women are in the menstrual phase of life and 60% have moderate to severe menstrual pain, or 17% of women. Previously our medical devices were classified as high risk class III by the US FDA. While our existing pilot clinical study for menstrual pain reported exceptional results for menstrual pain, to publish a clinical study and obtain US market clearance, we are collaborating with the University Hospital at Birmingham, UK. The researchers here are world renowned thought leaders in women's health and are conducting a double-blind randomized controlled trial to evaluate the efficacy of ActiPatch in reducing menstrual pain (clinicaltrials.gov listing NCT03394547). You can view the existing clinical evidence and our commercials at https://www.myallay.com/ Prevention of Episodic Migraines Headaches Migraines affect 36 million men, women and children in the United States alone. The facts are:
Chronic pain is now widely understood to be due to central sensitization, which leads to exaggerated pain perception. Migraine is no exception; since it is well known that sensitization of the trigeminovascular pain pathway can occur during a migraine attack. There is pilot data that ActiPatch can help mitigate this sensitization, so a study has been completed to determine the efficacy of ActiPatch in preventing chronic, episodic migraines. The data from the study will be analysed in the next few weeks. We believe this data will allow us to work towards developing a product as a migraine therapy and allowing us to obtain market clearance. Postoperative Recovery and Pain Working with our distributor in Lebanon we are conducting a double blind placebo randomized controlled trial on total knee replacement (clinicaltrial.gov NCT03395444). Through our long standing association with B. Braun UK, RecoveryRx has been determined to be a valuable aid in joint replacement surgery. This clinical study will allow us to gain worldwide recognition and allow for expanded marketing and acceptance of the RecoveryRx as a standard of post-operative care following joint replacement. Interstitial Cystitis (Overactive Bladder and Pelvic Pain) This study is a University of Texas, McGovern Medical School sponsored double blind randomized controlled trial. The goal is to determine how well the ActiPatch therapy works in treating patients with interstitial cystitis, bladder pain syndrome and overactive bladder. Interstitial cystitis and bladder pain syndrome are chronic bladder health conditions that greatly affect quality of life. These conditions create intermittent feelings of pain and pressure in the bladder area. The study is expected to recruit 60 women who are urology patients of the University's hospital. At least 35 million Americans have overactive bladder. Lower urinary tract symptoms, urgency, and pelvic pain are common complaints to urologists and primary care physicians. Additional Bioelectronic Product Opportunities As we develop the organizational structure we envision additional opportunities in chronic wounds, neuropathy, hypertensive therapy, etc. Most importantly future growth is not dependent on large capital outlays for research and development. Immediate Sales Growth We anticipate imminent solid sales growth from the following programs:
Thank you for your support. Sincerely,
______________________ |
FREDERICK, MD., May 31, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), maker of advanced medical devices announces that B. Braun Ltd, of Sheffield, UK has recently completed development of its same day surgical TOTAL Pathway program for joint replacements which includes BioElectronics medical devices. The program is being launched by B. Braun’s UK Group to improve care and reduce the UK healthcare cost of its 160,000 annual hip and knee replacement procedures.
The “fast-track” same day hip and knee replacements are being supported by hospital physiotherapy teams visiting the patient at home and communicating using a specialized wireless tablet. Each patient will be given an ActiPatch medical device and a prescription for 6 additional ActiPatch devices. A similar program is being implemented for spinal surgeries.
Phil Cleary, Senior Product Group Manager, stated that “our TOTAL Pathway program enhances our commitment to patient safety, post-operative care, as well as significantly reducing healthcare costs and hospital stays.” Treating post-surgical pain requires a multifaceted approach. In trials, ActiPatch was well received and produced positive outcomes. We look forward to making this program a success, in the UK and other countries where B. Braun operates.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.
About B. Braun Medical Ltd
B. Braun Medical Ltd, UK, https://www.bbraun.co.uk/ is a member of the B. Braun Group, https://www.bbraun.com/en.html one of the world´s leading healthcare companies. On an international level, B. Braun’s 54,000 employees are in 60 countries and are separated into additional divisions for hospital care, surgical products, outpatient care, and home care services.
Keep in mind partners are happening and licensed ones at that.
The back study will not go in as a new submission, it is included in the knee and ankle submission so this will happen quicker than most would believe. Well actually the back study will be added to the prior submission, I don't want to confuse you
Watch how huge the Co-Branding gets. How many names besides Pain Gear?
Increasing shareholder value=7 components of shareholder value.
• Revenue
• Operating Margin
• Cash Tax Rate
• Incremental Capital Expenditure
• Investment in Working Capital
• Cost of Capital
• Competitive Advantage Period
Within the next 120 days BIEL will have in place-
Full body clearance minus the Migraine, anticipated clearance at a later date based upon the fact that this is a preventative study and the patients must have signs of a migraine coming, this study is a little more complicated.
Licensed partners (Major)
Equity partners
At least 2 huge retail chains
Let’s add on a few more distributors. Why not? Lol
NHS-first week of April, keep in mind not the only week, this is lifetime!
There will be other EU States that will duplicate the NHS and this will be coupled with licenses being sold to partners. What price, how much in royalties will soon be determined.
The August financials will and should be the strength of evidence that a certain person has established a supply chain that will be second to none.
I should mention that sales makeup only one component of the revenue stream, this is where my opinion may differ from the good posters on the BIEL board.
Revenue is the total amount taken in by a business in a set period of time.
This can include royalties, license fees and equity from partners and sales.
BIEL cannot have millions in sales without including the other revenue streams mentioned above.
My revenue forecast including sales may be different than others.
Great rewards will follow in due time. Waiting on the FDA protocol. Which means pre-submission. Guidance, rules and timing will be part of the protocol.(Looks like May-June clearance.)
Migraine clinical results will still be the huge one for the FDA protocol.(August-September clearance on positive results.)
NHS is the first of many EU States getting on board. Pretty good health systems across the pond. Sweden next!
The back pain study will obtain US FDA clearance for relief of musculoskeletal pain. Migraine headaches are not musculoskeletal. Migraines and musculoskeletal pain are both neurological disorders. Two FDA clearances!!!!!!!!!!!!!
SEC-much ado about nothing!
Partners-much ado about something!
12/7/2017 - Try and Tell US Launch, gets a 7 Day ActiPatch to US residents for shipping and handling costs of $4.95
12/7/17 - BIEL closes a deal with ANDA for National Distribution, ANDA has 60,000 commercial customers and is owned by TEVA Pharma, TEVA has extensive business dealings with the NHS
1/4/2018 - ActiPatch gains admission to the UK NHS Drug Tariff as a covered medical device, The NHS is the largest single healthcare delivery organization in the world
1/9/2018 - CARE Pharmacies will be handling the ActiPatch, CARE is an organization of 90 pharmacies in 17 states, CARE will be educating patients on the benefits of drug-free pain relief through Pain Consultations
1/16/2018 - Allay Menstrual Clinical Study is fully enrolled, taking place at the prestigious Birmingham Women's Hospital,an NHS Foundation Hospital
1/22/2018 - BIEL signs deal with Performance Health, 120 outside sales reps, 40 inside reps, KN interview
1/22/2018 - BIEL signs deal with MundiPharma in Australia and 8 other countries, Mundi is associated with Purdue Pharma, KN interview
1/22/2018 - Back Pain Study is complete, BIEL has dialogue ongoing with FDA for submission of Study to expand ActiPatch indications, KN interview
1/22/2018 - Migraine Study will get the full attention of staff now that the Back Study has been completed
1/22/2018 - BIEL in talks with Walmart
1/22/2018 - Meeting scheduled with CVS
This is the last 2 months of activity for BIEL. Any other OTC company would be dancing in the Street if they had accomplished this much in the last year.
The NHS Approval has opened new doors for BIEL and will continue to do so for many years.
FREDERICK, Md., Jan. 04, 2018 (GLOBE NEWSWIRE) -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com makes wearable, drug-free chronic pain therapy medical devices. It is pleased to announce that the UK’s government-funded public health service, National Health System (NHS), has approved our application to cover and pay for ActiPatch® Musculoskeletal Pain Therapy. The NHS estimates that almost half of the 50 million UK adults may be living with chronic-pain¹, which is why there are more than 100,000 physician visits every day for musculoskeletal pain alone².
The ActiPatch is a drug-free, wearable medical device that regulates peripheral nerve activity to provide pain relief. The NHS based its decision considering strong clinical evidence and a health economics study, which found that ActiPatch significantly decreased pain and improved quality of life, while reducing overall healthcare costs by 42% (58.5% reduction in physician appointment costs, 35% reduction in prescription medication costs).
“This is a major win for pain sufferers in the UK, since they will now be able to obtain a prescription for ActiPatch, the cost of which will be covered by the government,” stated Ian Rawe, Ph.D., Director of Clinical Research at BioElectronics. “We commend this move by the NHS, as this will open up the doors for reimbursement in the US and other managed care markets. This will likely have a tremendous impact on our sales and marketability of the product in the UK and elsewhere,” said Keith Nalepka, VP of Sales & Marketing at BioElectronics.
With the addition of ActiPatch to list of approved treatments, chronic pain sufferers now have access to paid safe, drug-free chronic pain relief. The ActiPatch will be listed for payment coverage in April.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.
References
1 NHS, "NHS Choices," January 2018. [Online].http://www.actipatch.com/actipatch/wp-content/uploads/2014/11/ActiPatch-3-month-Cost-Study-Final.pdf
Available: https://www.nhs.uk/news/medical-practice/almost-half-of-all-uk-adults-may-be-living-with-chronic-pai....
2 Arthritis Research UK, "Muscloskeletal Matters," Keele University, 2009
ActiPatch Cost Assessment Study Used By UK's NHS
http://www.actipatch.com/actipatch/wp-content/uploads/2014/11/ActiPatch-3-month-Cost-Study-Final.pdf
This improvement translated into reduced utilization of healthcare services, leading to a 36.8% reduction in health care costs to the NHS over a 3-month period, even after accounting for the cost of the ActiPatch device
Conclusion
Utilizing ActiPatch® as a chronic pain therapy treatment improves patient quality of life, while reducing the economic burden to the NHS.
"Almost half the adult population is living with chronic pain," the Daily Mail reports. A major new review suggests that around 28 million adults in the UK are affected by some type of chronic pain (pain that lasts for more than three months). Read More Link
https://www.nhs.uk/news/medical-practice/almost-half-of-all-uk-adults-may-be-living-with-chronic-pain/
February 06, 2017 09:05 ET
FREDERICK, MD--(Marketwired - Feb 6, 2017) - BioElectronics Corporation (OTC PINK: BIEL), the maker of wearable pain therapy devices, announced today that it has received over-the-counter use market clearance from the US FDA for ActiPatch® for the adjunctive treatment of musculoskeletal pain related to (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee.
BioElectronics is an electroceutical company that develops wearable, neuromodulation devices to safely mitigate neurological diseases and improve quality of life. Our innovative pulsed shortwave therapy technology (PSWT) that uses low power pulsed electromagnetic fields regulate electrical activity of the nervous system. The neuromodulation basis of PSWT presents significant opportunities for BioElectronics to develop optimized technology for diabetic neuropathy, postoperative surgery, chronic wounds, and other applications.
Our current OTC product line includes ActiPatch® Musculoskeletal Pain Therapy, Allay® Menstrual Pain Therapy, Smart Insole™ Heel Pain Therapy, and RecoveryRx® Post-operative and Chronic Wounds Therapy. The US FDA clearance is for our flagship product the ActiPatch® Musculoskeletal Pain Therapy, developed to relieve chronic pain. ActiPatch is a drug-free, wearable nonprescription medical device that provides 720-hours (90, 8-hour treatments) of on/off therapy for $30.00 retail. Most users obtain relief with only 8 hours per day of use, so the device will generally last several months, depending on use. ActiPatch Provides:
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.
How to Order an ActiPatch®?
Visit tryactipatch.com to place your order for the ActiPatch® today.
www.tryactipatch.com
BioElectronics Corporation
301-874-4980
info@bielcorp.com
4539 Metropolitan Court
Frederick, MD 21704
ActiPatch Healthcare Utilization Study Link
http://www.harmonyhealth.se/wp-content/uploads/2017/10/ActiPatchHealthcareCostStudy.pdf
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